Is Science or Policy Preference Leading the Way? Comments on the FDA Medicinal Nicotine Webcast

Early afternoon, on Dec. 12, 2017, I sat in on the Duke/Margolis Center for Health Policy’s webcast, “FDA’s New Regulatory Framework for Tobacco and Nicotine: The Role of Medicinal Nicotine.” This two-hour webcast featured Dr. Scott Gottlieb, the new Food and Drug Administration (FDA) Commissioner, as keynote speaker, with a distinguished panel of six individuals representing the FDA, Tobacco-Free Kids, GlaxoSmithKline Consumer Healthcare and the academic community. The panelists considered the role of medicinal nicotine in future tobacco control efforts, given the FDA’s commitment to a new nicotine-based policy and the reduction of cigarette nicotine to non-addictive levels.

My main interest in the webcast was to gain insight into the intentions of leading American tobacco-control advocates. Historically, policy has been guided by a preconceived notion that abstinence is the only appropriate course of action – and research has generally been aimed towards that end goal. I wanted to find out whether this administration’s tobacco control policy is based on science and public health principles or on fixed policy guidelines that dictate what research is to be considered or disregarded by federal authorities – and why.

The FDA has recently disregarded evidence demonstrating the efficacy of e-cigarettes, related vapor products (Electronic Nicotine Delivery Systems, or “ENDS”) and smokeless tobacco for both risk reduction and smoking cessation. The agency also believes that ENDS are attracting large numbers of young non-smokers to nicotine despite substantial evidence to the contrary.

The reality is that cigarettes are, by far, the most hazardous and most addictive tobacco-related products on the market. Though federal agencies recognize the distinctive risk posed by combustible cigarettes, they refuse to endorse ENDS and smokeless products for tobacco harm reduction, believing that such endorsement would recruit large numbers of non-smokers to tobacco use.

We can all agree that it is best never to use tobacco products or, once one has started, to quit. Unfortunately, most smokers cannot quit on their own or with the current medicinal nicotine products. For them, substituting cigarettes with a lower-risk product that satisfies their urge to smoke – i.e., tobacco harm reduction – would appear to be the best option.

However, several barriers to tobacco harm reduction efforts exist. One such barrier is the insistence that smoking is a disease. True, addiction to cigarettes is a disease for some smokers. For all, however, it is a behavior that can be addressed by encouraging simple substitution with lower-risk products that can satisfy the urge to smoke.

The second major barrier includes the fact that federally-funded research has mostly been limited to potential hazards of both tobacco and nicotine use. Combined with the government’s dismissal of data on the personal and public health benefits of tobacco harm reduction, this barrier results in research that starts with hypotheses seeking to confirm only one potential outcome of e-cigarettes and other reduced-risk products.

But perhaps the most important barrier to overcome is the fear of the gateway effect. The limited research that has been done in support of this hypothesis clearly shows that e-cigarettes are overwhelmingly used by current and former smokers, not teens taking up smoking for the first time. This being the case, the FDA’s new top priority should be setting aside the conceptual barriers noted above and determining whether e-cigarettes act as a gateway either towards or away from combustible cigarette use.

Overall, my attendance at the webcast and reading of this literature has left me with the impression that, despite hype to the contrary, science has nothing to do with tobacco control policy as it relates to tobacco harm reduction. The FDA’s policy is instead based entirely on traditional thinking within the tobacco control community, with so-called “science” limited to promoting pre-determined policy guidelines.